NCT01889420

Phase I Trial of Everolimus, Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to test the possibility that a combination of three drugs, pomalidomide and everolimus with dexamethasone, may improve patient responses when compared with use of either drug alone, with dexamethasone in refractory/relapsed multiple myeloma.

Detailed description

Given that pomalidomide is an FDA approved drug for patients with relapsed or progressive myeloma, and everolimus has been shown to have single agent activity in relapsed myeloma, it seems reasonable to combine these two active drugs in patients with relapsed/refractory disease. Given that low dose dexamethasone dramatically improved the response rate of pomalidomide, this drug will be added to the combination.

Conditions

• Multiple Myeloma in Relapse

Interventions

Type	Name	Description
DRUG	Combination therapy	Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone. Cycles will span 28 days. Dosage schedules will be: 1. Everolimus daily for 28 days of a 28 day cycle; 2. Pomalidomide daily for 21 days of a 28 day cycle 3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2013-06-28
• Last updated: 2015-07-31
• Results posted: 2015-07-31

Locations

1 site across 1 country: United States